The companies intend to launch a proof-of-concept clinical trial of Novo Nordisk’s semaglutide in conjunction with Gilead’s cilofexor and firsocostat.
Semaglutide is a GLP-1 analogue originally developed to treat type 2 diabetes in adults. Cilofexor is a FXR agonist, while firsocostat is designed to inhibit ACC.
The partnership will use Novo Nordisk’s expertise in diabetes and metabolism, along with Gilead’s expertise in liver disease and combination therapies.
Novo Nordisk chief science officer and executive vice-president Mads Krogsgaard Thomsen said: “By combining the leading molecular science and clinical expertise of our two companies within the rapidly expanding liver and metabolic diseases, we aim to develop innovative, new and effective combination therapies to help people with NASH.”
The partners may also conduct preclinical research to improve understanding of NASH, which is a progressive liver disease that leads to fat accumulation and inflammation in the organ.
If left untreated, the condition could result in end-stage liver disease, liver cancer, and other serious complications.
Gilead chief scientific officer and Research and Development head John McHutchison said: “We look forward to working with the Novo Nordisk team to explore opportunities to advance our complementary research capabilities and approaches in NASH to help address this significant unmet need for patients.”
In February this year, Gilead reported that experimental drug selonsertib failed in the Phase III STELLAR-4 trial of patients with compensated cirrhosis (F4) caused by nonalcoholic steatohepatitis (NASH).
The trial did not meet the week 48 primary endpoint of a ≥1-stage histologic improvement in fibrosis without worsening NASH.